Medical device licence · 27545 · Class 2
PLATELET AGGREGATION REAGENT
Yes: licensed in Canada
Licence status Issued (active); first licensed February 16, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 27545
- Licence holder
- Helena Laboratories, CorpBeaumont, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- February 16, 2001
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PLATELET AGGREGATION KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.